Purification and Formulation of Biotechnological Drug Products

The course is intended to cover principles and general requirements for the development of biotechnological medicinal products from the isolation and the purification of the active substances to the formulation of pharmaceutical dose forms. References are made to the quality assays, compendial and not, to characterize active substances and dosage forms. Regulatory aspects relevant to production and marketing are also addressed.

At the end of the course, the student will acquire principles required to design biotechnological medicinal products, based on the specific properties of the active substance and the therapeutic requirements. Starting from the main chemical-physical characteristics of the molecules, the student will be able to propose the most suitable methods to produce, isolate and purify the related drug substances under sterile conditions according to the Good Manufacturing Practices.
Thanks to the knowledge and understanding acquired, the student will be able to individuate the criticisms and to define an appropriate control strategy in the attempt to satisfy the Regulatory Agencies' requirements.